Total Marrow Irradiation for Refractory Acute Leukemia | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT00686556

Total Marrow Irradiation for Refractory Acute Leukemia
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

RATIONALE: Giving chemotherapy and total marrow irradiation before a donor umbilical cord blood or hematopoietic stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase I trial is studying the side effects and best dose of total marrow irradiation when given together with combination chemotherapy and umbilical cord blood hematopoietic stem cell transplant in treating patients with acute leukemia, acute myeloid leukemia or multiple myeloma that did not respond to previous therapy.

Status: 
Recruiting
Study Date: 
Wed, 08/01/2012 to Fri, 09/01/2017
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: cyclophosphamide 60 mg/kg/day intravenous x 2 days pre-transplant, total dose 120 mg/kg Other Name: Cytoxan Drug: cyclosporine Beginning on Day -3 pre-transplant maintaining a level of >200 ng/mL. CSA dosing will be monitored and altered as clinically appropriate by Pharm D or physician, and discontinue at approximately day + 180 post-transplant. Other Name: CSA Drug: Fludarabine 25 mg/m2/day intravenous as a 1 hour infusion for consecutive 3 days pre-transplant, total dose 75 mg/m2 Other Name: Fludara Drug: mycophenolate mofetil Beginning on day -3, use intravenous route between days -3 and +5, followed by oral administration on Day +6 through +30, if tolerated. 15mg/kg/dose for patients <40 kg, 3 gm/day for patients >40 kg. Other Name: MMF Radiation: total marrow irradiation Dose escalating schedule per Cohort (TMI: 300 cGy) once daily. Other Name: TMI Procedure: umbilical cord blood transplantation product will be infused via intravenous drip on Day 0 according to current University of Minnesota guidelines for Umbilical Cord Blood Grafts Other Names: umbilical cord blood allogeneic hematopoietic stem cell transplantation Biological: Granulocyte colony-stimulating factor 5 mcg/kg/day intravenous or subcutaneous based on body weight beginning on Day +1 after umbilical cord blood infusion until absolute neutrophil count exceeds 2.5 x 10^9/L for 3 consecutive days. Other Name: G-CSF Biological: HLA-matched related donor bone marrow Related donor bone marrow or mobilized stem cells will be collected (target cell dose 5x10^8 nucleated cells/kg recipient weight, minimum 3x10^8 nucleated cells/kg recipient weight) and infused without processing on day 0 according to University of Minnesota Blood and Marrow Transplant Program guidelines. Other Name: mobilized peripheral blood stem cells